Clinical Evaluation of EUS-FNA on Diagnosis of Pancreatic Cystic Lesions

Xiaoyin Zhang

Status: Unknown

Conditions: Pancreatic Cyst

Treatments: Procedure: EUS-FNA

Study type: Interventional

Funder types: Other

Identifiers

NCT02041897

PCL-EUS-FNA

Details and patient eligibility

About

It is still controversial about the necessity of endoscopy ultrasound guide fine needle aspiration (EUS-FNA) on diagnosis of pancreatic cystic lesions(PCL).The aim of this study is to find the influence of EUS-FNA on diagnosis and suggestions of EUS specialists.

Full description

First, the investigators will send only EUS images of patients with PCL to diagnosis committee that is consisted with 8 EUS specialists from different countries.The diagnosis will be collected. Then the investigators send the results of EUS-FNA. The diagnosis and suggestions will be collected again. The investigators will calculate how much diagnosis has been changed because of results of EUS-FNA. The investigators will also follow up these patients for 5 years at least to find if these patients benefit from EUS-FNA and complications such as needle tract seeding metastases.

Enrollment: 160 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adults with ages from 18-80 years old.
2. The patients with pancreatic cystic lesions, which diameter of cystic lesion more than 2cm.
3. Sign the informed consent voluntarily. -

Exclusion criteria

1. The patient can't accept the endoscopic procedure.

2. The patient has blood coagulation dysfunction.

3. The patient has mental disorders.

4. The patient has mild or severe cardiorespiratory insufficiency.

5. The patient has hypertension and can't be controlled to safe level.

6. Patients with alcohol dependence.

7. Pregnant and lactating women.

8. The patients the investigators don't think suitable for this study.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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160 participants in 1 patient group

EUS-FNA, Rate of chang on diagnosis

Other group

Description:

It is a single arm study. We will conclude by calculating the rate of change of diagnosis before and after getting the results of EUS-FNA.

Treatment:

Procedure: EUS-FNA